Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease

2013. szeptember 13. frissítette: University of Medicine and Dentistry of New Jersey

A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies

RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.

A tanulmány áttekintése

Részletes leírás

OBJECTIVES:

Primary

  • Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease.
  • Determine the efficacy of this regimen in these patients.

Secondary

  • Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity.

OUTLINE: This is a pilot study.

  • Rituximab therapy: Patients receive rituximab IV on days -1, 6, 13, and 20. Treatment repeats approximately every 4 months in the absence of disease progression or unacceptable toxicity.
  • Donor lymphocyte infusion: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks (alternating with courses of rituximab therapy) for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Peripheral blood is collected periodically during study for correlative laboratory studies. Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction. Survival of donor lymphocytes is assessed by chimerism studies.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

2

Fázis

  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • New Jersey
      • New Brunswick, New Jersey, Egyesült Államok, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

DISEASE CHARACTERISTICS:

  • Histologically confirmed lymphoproliferative disease

    • CD20-positive disease
  • Bidimensionally measurable disease OR abnormal cells detected in blood
  • Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies* AND meets 1 of the following criteria:

    • Disease with anticipated response rate < 20% after treatment with rituximab alone, including any of the following:

      • Diffuse large cell lymphoma
      • B-cell lymphoblastic lymphoma
      • Burkitt's lymphoma
      • Acute lymphocytic leukemia
    • Relapsed or progressive disease after prior treatment with rituximab, including any of the following:

      • Hodgkin's lymphoma
      • Hairy cell leukemia
      • Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria:

        • Received prior fludarabine phosphate-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
        • Received prior anti-CD52 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
        • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
      • B-cell prolymphocytic leukemia meeting any of the following criteria:

        • Received prior fludarabine phosphate- or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
        • Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
      • Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:

        • Received prior fludarabine phosphate- and/or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
        • Received prior anti-CD20 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy
        • Received prior radioconjugated anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy
        • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
      • Multiple myeloma meeting any of the following criteria:

        • Received prior alkylating agent-, thalidomide-, corticosteroid-, or bortezomib-containing regimens and relapsed after 1 year of treatment OR ineligible to receive such therapies due to comorbidities or allergies
        • Received prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
      • Mantle cell lymphoma meeting the following criteria:

        • Received prior combination chemotherapy and anti-CD20 monoclonal antibody therapy and relapsed after treatment OR ineligible to receive such therapy
      • Diffuse large B-cell lymphoma meeting any of the following criteria:

        • Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
        • Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR not a candidate to receive such therapy
        • Received prior radiolabeled anti-CD20 monoclonal antibody therapy for transformed large cell lymphoma OR ineligible to receive such therapy
      • Burkitt's lymphoma meeting any of the following criteria:

        • Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
        • Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
      • Lymphomatoid granulomatosis meeting any of the following criteria:

        • Received prior single-agent or combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
        • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
      • Acute lymphocytic leukemia meeting any of the following criteria:

        • Received prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses and relapsed during or after treatment OR ineligible to receive such therapy
        • Received prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplantation (HSCT) and relapsed after treatment OR not a candidate for such therapy
        • Received prior treatment with chemotherapy with or without radiotherapy followed by allogeneic HSCT and relapsed after treatment (or not a candidate for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization, or molecular (reverse transcriptase-polymerase chain reaction) evidence of the bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate NOTE: *Not eligible to receive standard available salvage regimens anticipated to result in durable remission
  • No active CNS malignancy
  • Not considered a candidate for allogeneic HSCT
  • HLA-partially matched (≥ 2/6) related donor available

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • Not pregnant
  • Negative pregnancy test
  • Fertile women must use effective contraception
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST < 3.0 times ULN
  • Cardiac ejection fraction > 35%
  • Absolute neutrophil count > 1,000/mm³ (without cytokines)
  • Platelet count > 50,000/mm³ (untransfused)
  • No significant organ dysfunction
  • No active uncontrolled infections
  • No hypersensitivity reaction to rituximab that has precluded completion of a 4-week course of rituximab therapy
  • No uncontrolled psychiatric illness or medical condition that would preclude tolerance of study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy for at least 7 days
  • More than 30 days since prior cytotoxic chemotherapy
  • At least 14 days since prior steroids
  • At least 14 days since prior radiotherapy to non-target lesions

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Therapeutic allogeneic lymphocytes with rituximab
Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).
The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Időkeret
Toxicity as assessed by NCI CTCAE v3.0
Időkeret: 4 years
4 years

Másodlagos eredményintézkedések

Eredménymérő
Időkeret
Efficacy
Időkeret: 4 years
4 years

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2005. január 1.

Elsődleges befejezés (Tényleges)

2008. február 1.

A tanulmány befejezése (Tényleges)

2008. február 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2005. szeptember 12.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2005. szeptember 12.

Első közzététel (Becslés)

2005. szeptember 15.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2013. szeptember 17.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2013. szeptember 13.

Utolsó ellenőrzés

2013. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • CDR0000540171
  • P30CA072720 (Az Egyesült Államok NIH támogatása/szerződése)
  • CINJ-010406 (Egyéb azonosító: Cancer Institute of New Jersey)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a rituximab

3
Iratkozz fel